Phase 3
N=420
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
Bleeding Cardiac Surgery Patients
Bottom Line
View on ClinicalTrials.gov: NCT05523297 ↗Enrolled (actual)
420
Serious AEs
41.7%
Results posted
Aug 2025
Primary outcome: Primary: Number of Patients Requiring Additional Hemostatic Intervention — 166; 125; 47; 82 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octaplex (Drug); Frozen Plasma Product, Human (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Requiring Additional Hemostatic Intervention |
166; 125; 47; 82 | <0.0001 sig |
| SECONDARY Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels |
56; 83; 157; 122 | 0.0022 sig |
| SECONDARY Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. |
471.20; 641.90; 690.90; 922.90 | <0.0001 sig |
| SECONDARY Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). |
183; 136; 30; 71; 176; 129 | <0.0001 sig |
| SECONDARY Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. |
6.61; 13.79 | <0.0001 sig |
| SECONDARY Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. |
6.61; 9.33 | 0.0015 sig |
| SECONDARY Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. |
4.14; 6.73; 5.20; 8.87 | 0.0010 sig |
| SECONDARY Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. |
0.19; 4.70; 0.19; 0.23; 1.05; 2.02 | <0.0001 sig |
| SECONDARY Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. |
205; 200; 8; 7; 116; 75 | 0.8364 |
| SECONDARY Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups |
167; 159; 46; 48; 211; 197 | 0.6956 |
| SECONDARY Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups |
200; 189; 13; 18; 199; 187 | 0.3782 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration. |
-0.9; -0.7 | 0.0081 sig |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT) |
-10.3; -0.7 | 0.6735 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT) |
-63.5; -45.6 | 0.9033 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity |
0.1; 0.5 | 0.1808 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT |
-21.5; -21.7 | 0.9698 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF |
3.6; 6.7 | 0.3363 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF |
3.8; 1.4 | 0.5736 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks |
-2.3; 10.9 | 0.2667 |
| SECONDARY Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks |
-5.9; -18.2 | 0.0658 |
| SECONDARY Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups. |
1.0; 1.2 | 0.0726 |
| SECONDARY Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups |
77; 98 | — |
| SECONDARY Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups |
1.0; 1.0 | — |
| SECONDARY Comparison of the Duration of ICU Stay Between Octaplex and FP Groups |
4; 4 | — |
| SECONDARY Comparison of the Duration of Hospitalization Between Octaplex and FP Groups |
8; 9 | — |
| SECONDARY Comparison of the Incidence of Death Between Octaplex and FP Groups |
7; 8 | 0.7497 |
| SECONDARY Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups |
21.0; 21.0 | — |
Summary
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
- Coagulation factor replacement with PCC or FP ordered in the operating room for:
- Management of bleeding, or
- Anticipated bleeding in a patient who has been on-pump for >2 hours or has undergone a complex procedure (e.g., aortocoronary bypass [ACB] plus aortic valve replacement)
- Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time [CT] or INR) or suspected based on the clinical situation
- Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.
Exclusion Criteria
- Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump [IABP]) or repair of thoracoabdominal aneurysm
- Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
- Severe right heart failure (clinical diagnosis ± echocardiography)
- Known contraindications to heparin
- PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
- Known thromboembolic event (TEE) within 3 months prior to surgery
- History of severe allergic reactions to PCC or FP
- Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA
- Refusal of allogeneic blood products
- Known pregnancy
- Currently enrolled in other interventional clinical trials
Data sourced from ClinicalTrials.gov (NCT05523297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.